Chronic PJIsNCT04371068
Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)
An observational study of Chronic PJIs, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic PJIs
- What is being tested?
- Culture of removed prosthesis using DTT
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with painful prosthesis or prosthesis loosening <10 years treated at the CRIOAc Lyon
Who may be able to join
- Adult patients with painful prosthesis or prosthesis loosening <10 years
- without mechanical explanation,
- without clinical evidence of infection (no fistula, no abscess, no discharge, no local inflammation),
- without microbiological diagnosis (absence of preoperative joint puncture (not performed or not feasible) or with a culture-negative preoperative joint puncture).
Who cannot join
- Patients with painful prosthesis or prosthesis loosening
- with mechanical explanation,
- or with clinical evidence of infection (fistula, abscess, discharge, local inflammation),
- with a previous microbiological diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the microDTTect Device (Heraeus) in the Diagnosis of Low-grade Chronic
Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.
In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.
Read the detailed description
Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.
In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.
- Conditions
- Chronic PJIs
- Being tested
- Culture of removed prosthesis using DTT
- Keywords
- bone and joint infection, biofilm, joint arthroplasty, implant failure, prosthetic joint infection, dithiothreitol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culture of removed prosthesis using DTTBiological
No specific or supplementary intervention is performed among patients. The included patients have scheduled surgery consisting of prosthesis removal or change. Instead of being discarded, the prosthesis which was removed during the surgery was sent to the laboratory using the MicroDTTect system and bacterial culture was performed with the fluid obtained. Results will be then compared to classical culture of periprosthetic tissues (PPT).
| Study group | Role | What they receive |
|---|---|---|
| Patients suspected of low-grade PJIs | Adult patients suspected of low-grade PJIs, who have a scheduled prosthesis removal or change and who meet the inclusion criteria Receives: Biological: Culture of removed prosthesis using DTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bacteria isolated isolated
type of bacteria isolated
Measured: every day until 15 days of culture
Secondary outcomes (1)
time to positivity of cultures
time to positivity of cultures of the fluid obtained after prosthesis treatment using the MicroDTTect system in comparison with conventional culture of PPT samples
Measured: every day until 15 days of culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Mar 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PJIsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugénie MABRUT, Hospices Civils de Lyon
- Investigators
- FREDERIC LAURENT, Principal investigator, LAURENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371068
- Sponsor's protocol ID
- 18-265
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the microDTTect Device (Heraeus) in the Diagnosis of Low-grade Chronic
- ClinicalTrials.gov ID
- NCT04371068
- Acronym / sponsor ID
- 18-265
- Conditions
- Chronic PJIs
- Keywords
- bone and joint infection, biofilm, joint arthroplasty, implant failure, prosthetic joint infection, dithiothreitol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.
In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.
Detailed description
Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.
In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of low-grade PJIs | – | Biological: Culture of removed prosthesis using DTTAdult patients suspected of low-grade PJIs, who have a scheduled prosthesis removal or change and who meet the inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with painful prosthesis or prosthesis loosening <10 years treated at the CRIOAc Lyon
Key inclusion criteria (4 listed)
- Adult patients with painful prosthesis or prosthesis loosening <10 years
- without mechanical explanation,
- without clinical evidence of infection (no fistula, no abscess, no discharge, no local inflammation),
- without microbiological diagnosis (absence of preoperative joint puncture (not performed or not feasible) or with a culture-negative preoperative joint puncture).
Key exclusion criteria (4 listed)
- Patients with painful prosthesis or prosthesis loosening
- with mechanical explanation,
- or with clinical evidence of infection (fistula, abscess, discharge, local inflammation),
- with a previous microbiological diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culture of removed prosthesis using DTTNo specific or supplementary intervention is performed among patients. The included patients have scheduled surgery consisting of prosthesis removal or change. Instead of being discarded, the prosthesis which was removed during the surgery was sent to the laboratory using the MicroDTTect system and bacterial culture was performed with the fluid obtained. Results will be then compared to classical culture of periprosthetic tissues (PPT). | Biological | Patients suspected of low-grade PJIs |
Primary outcome
Rate of bacteria isolated isolated
Time frame: every day until 15 days of culture
type of bacteria isolated
1 secondary outcome
time to positivity of cultures
Time frame: every day until 15 days of culture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- website of CRIOAc LyonLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FREDERIC LAURENT principal investigator
LAURENT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic PJIs, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of bacteria isolated isolated (time frame: every day until 15 days of culture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.